Reported May 19, 2021 · Ongoing
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are…
St. Jude Medical, Cardian Rhythm Management Division
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St. Jude Medical, Cardian Rhythm Management Division · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
- ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
- Lot codes and dates
- Endurity
- Pacemaker Model Number/UDI (GTIN)PM1160 / 05414734507042 PM2160 / 05414734507059 PM1152 / 05414734509763 PM2152 / 05414734509770 PM1172 / 05414734509596
- PM2172 / 05414734509602 Serial Numbers77
4,049 of 4,049 codes
764983176506907650710765071276507137650715765071876507277650742765080076508017650802765080676508097650811765081576508167650817765081876508207650821765082276508237650824765082676509697650971765097476509757650976765097876509797650980765098276509837650984765098576509867650987765098876509897650990765099276509937650994765099576509977650998765100076510017651002765100476510057651006765100876510107651011765101276510147651015
- Amount recalled
- 95,042 pacemakers [updated 03/20/2023]
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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